NL-OMON36042已完成2 期
An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD) (CS005) - The long term effect of EndoStim
EndoStim0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subject has a history of heartburn, regurgitation or both for >6 month. Baseline GERD HRQL heartburn score of >= 20 off PPI assessed during the run in phase.
- •Excessive acid exposure during 24-hour pH-metry of antisecretory therapy
排除标准
- •Subject has any non-GERD esophageal motility disorders.
- •Subject has gastroparesis.
- •Subject has a hiatal hernia larger than 3 cm.
- •Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease.
- •Subject is pregnant or intends to become pregnant during the trial period.
- •History of previous esophageal or gastric surgery, including nissen fundoplication.
研究者
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